Slide Set - SAEM May 2006

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Slide Set - SAEM May 2006

  1. 1. Neurological Emergencies Treatment Trials SAEM 2006
  2. 2. Disclaimer • We don’t have authoritative answers to any of your questions • We have applied to be the Clinical Coor- dinating Center for this application, but this has not been awarded to anybody yet • We do not represent the NINDS or any agency here, we are just sharing personal opinions based on having thought a lot about this network
  3. 3. History • Oct 2003 - first organizational NET*2 meeting • Mar 2004 – NIH conference on ENTCN • 2004-2005 NET*2 investigator initiated planning and pilot trial grant applications / surveillance • Nov 2005 – RFA for NETT Coordinating Center • Apr 2006 – RFA for NETT Hubs and SDMC
  4. 4. Defining Principals • Set forth by NINDS • Very early enrollment • Diverse enrollment, hub and spoke design • Large simple trials
  5. 5. Operational Principals • Our vision • Streamlined operations • Technological efficiencies when possible • Centralized outcome assessments • Clinical translation
  6. 6. Impact • Opportunity to advance care of patients with neuro-emergencies • Large NIH investment in emergency medicine clinical research • Re-engineering the clinical research enterprise
  7. 7. What does an application need? • We don’t really know • Enrollment • Experience • Collaboration
  8. 8. Enrollment • Sufficient patient volume • Access to diverse diagnoses – Adults and children – Neurotrauma, TBI and SCI – Stroke, ischemic and hemorrhagic – Seizure, meningitis, anoxic injury • Local infrastructure
  9. 9. Experience • ED clinical trials (any disease) • Institutional track record • Cross disciplinary research
  10. 10. Collaboration • Emergency Medical Services • Spokes – Diversity – Buy in • Cross disciplinary – Emergency Medicine – Neuro-Critical Care – Neurology / Neurosurgery – Trauma surgery
  11. 11. Spokes • Don’t have to use all spokes for all trials • Look for areas of concentration – Trauma – Stroke – EMS expertise
  12. 12. Budget suggestions • Include all effort needed to: – Set up the program – Prepare potentially complex IRB apps – Enroll subjects in two trials, best guess – Collect and report data – Provide informatics support • Include – Travel to investigator meetings
  13. 13. Budget suggestions
  14. 14. Resources • RFA for the 3 components • ENCTN final report • UM CCC application • Links to all available at http://sitemaker.umich.edu/NETT

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